Drugs

Teleflex Recalls Percutaneous Thrombolytic Device

Teleflex has recalled its Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device (PTD) Kit, 7FR, after receiving reports about the inner lumen becoming detached from the device’s basket. The PTD catheter is used with the Arrow Rotator Drive Unit to permit mechanical declotting of native arterio-venous fistulae and synthetic dialysis grafts, according to a recall notice. Affected devices were manufactured from 10/2019 through July of this year.

“If the orange inner lumen detaches from the basket, health consequences depend upon whether, and where, the fractured tip component embolizes,” the notice says. “In most cases, the embolization is local to the treatment target site, allowing retrieval with an additional intervention and consequent delay of therapy. In some cases, the embolization could be central or peripheral and result in, or threaten to cause, local ischemia. Such an occurrence could require a more complex catheter-based intervention for retrieval, or rarely, surgical retrieval.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome